Conditions in which the subject's identity cannot be linked, even by the researcher, with his or her individual responses

Assent to Participate in Research

A child's affirmative agreement to participate in research

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Autonomous Agents

Prospective subjects who are informed about a proposed study and who can voluntarily choose whether to participate

Benefit-risk Ratio

Ratio considered by researchers and reviewers of research as they weigh potential benefits (positive outcomes) and risks (negative outcomes) of a study; used to promote the conduct of ethical research

Breach of Confidentiality

Accidental or direct action that allows an unauthorized person to have access to raw study data

Coercion

Overt threat of harm or excessive reward intentionally presented by one person to another in order to obtain compliance; an example is offering prospective subjects a large sum of money to participate in a dangerous research project

Confidentiality

Management of private data in research in such a way that only the researcher knows the subjects’ identities and can link them with their responses

Consent Form

Written form, tape recording, or videotape used to document a subject's agreement to participate in a study

Covered Entities

Public or private entity that processes or facilitates the processing of health information

Covert Data Collection

Data collection that occurs without subjects’ knowledge or awareness

Data Use Agreement

Agreement that limits how the data set with health information may be used and how it will be protected in research

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Deception

Misinforming subjects for research purposes. After a study is completed, subjects must be debriefed or informed of the true purpose and outcomes of a study so that areas of deception are clarified

Diminished Autonomy

Condition of subjects whose ability to give informed consent voluntarily is decreased because of legal or mental incompetence, terminal illness, or confinement to an institution

Discomfort and Harm

Phrase used to describe the degree of risk for a subject participating in a study. These levels of risk include no anticipated effects, temporary discomfort, unusual levels of temporary discomfort, risk of permanent damage, or certainty of permanent damage

Ethical Principles

Principles of respect for persons, beneficence, and justice that are relevant to the conduct of research

Principle of Beneficience

Ethical principle that encourages researchers to do good and “above all, do no harm.”

Principle of Justice

Ethical principle stating that human subjects should be treated fairly

Principle of Respect for Person(s)

Principle indicating that each person has the right to self-determination and the freedom to participate or not participate in research

Fabrication

A form of scientific misconduct in research that involves making up results and recording or reporting them

Falsification

A type of scientific misconduct that involves manipulating research materials, equipment, or processes, or changing or omitting data or results, such that the research is not accurately represented in the research record

Human Rights

Claims and demands that have been justified in the eyes of an individual person or by the consensus of a group of people and are protected in research

Individually identifiable health information

any information collected from an individual that is created or received by healthcare provider, health plan, or healthcare clearinghouse; related to past, present, or future health condition, the provision of health care , or the past, present, or future payment for the provision of health care, and identifies the individual; or with respect to which there is a reasonable basis to believe that the information can be used to identify the individual

Informed Consent

Agreement by a prospective subject to participate voluntarily in a study after he or she has assimilated essential information about the study

Institutional Review

Process of examining studies for ethical concerns by a committee of peers

Complete Review

Type of institutional review process for studies with risks that are greater than minimal. The review of a study is extensive or complete by an institutional review board

Exempt from Review

Designation given to studies that have no apparent risks for the research subjects and thus are designated as exempt by an institutional review board

Expedited Review

Institutional review process for studies that have some risks, but the risks are minimal or no greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations

Institutional Review Board (IRB)

A committee that reviews research to ensure that the investigator is conducting the research ethically

Invasion of Privacy

Sharing private information with others without a person's knowledge or against his or her will

Minimal Risk

Research subject's risk of harm anticipated in the proposed study that is not greater, considering probability and magnitude, than that ordinarily encountered in daily life or during the performance of routine physical or psychological examinations

Nontherapeutic Research

Research conducted to generate knowledge for a discipline; the results might benefit future patients but will probably not benefit the research subjects

Permission to Participate in Research

The agreement of parent(s) or guardian to the participation of their child or ward in research

Plagiarism

A type of scientific misconduct with appropriation of another person's ideas, processes, results, or words without giving appropriate credit, including those obtained through confidential review of others’ research proposals and manuscripts

Privacy

Freedom to determine the time, extent, and general circumstances under which private information will be shared with or withheld from others

Research Misconduct

Intentional deviation from practices commonly accepted within the scientific community for proposing, conducting, or reporting research. May include fabrication, falsification, or plagiarism; does not include honest errors or honest differences in interpretation or judgment of data

Therapeutic Research

Research that provides a patient with an opportunity to receive an experimental treatment that might have beneficial results

Voluntary Consent

Decision made by a prospective subject, of his or her own volition, without coercion or any undue influence, to participate in a research study